The FDA Ruled That ZYN Pouches Are Safer Than Cigarettes. That Doesn’t Mean They’re Safe
The FDA Ruled That ZYN Pouches Are Safer Than Cigarettes. That Doesn’t Mean They’re Safe
美国食品药品监督管理局（FDA）裁定 ZYN 尼古丁袋比香烟更安全，但这并不意味着它们是无害的
On June 30, the US Food and Drug Administration authorized 20 ZYN nicotine pouch products to carry a specific “modified risk” claim. This means that in the US, ZYN can now assert that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” 6月30日，美国食品药品监督管理局（FDA）批准了 20 款 ZYN 尼古丁袋产品，允许其标注特定的“风险改良”（modified risk）声明。这意味着在美国，ZYN 现在可以宣称：“使用 ZYN 代替香烟，可以降低患口腔癌、心脏病、肺癌、中风、肺气肿和慢性支气管炎的风险。”
The decision does not mean nicotine pouches are safe or approved as smoking cessation products. It simply allows Swedish Match, which manufactures ZYN, to market certain products as a less harmful alternative for adults who completely switch away from cigarettes. 这一决定并不意味着尼古丁袋是安全的，也不代表它们被批准为戒烟产品。它仅仅是允许 ZYN 的制造商瑞典火柴公司（Swedish Match）将某些产品作为一种危害较小的替代品，向那些完全戒掉香烟的成年人进行营销。
The regulatory green light comes at a time when the nicotine-pouch boom has already reshaped the conversation about alternatives to smoking. Nicotine pouches have become one of the fastest-growing nicotine categories globally, fueled by their discreet nature, lack of smoke or vapor, and growing perceptions that they represent a “cleaner” form of nicotine consumption. 此次监管部门的“绿灯”放行，正值尼古丁袋的兴起已经重塑了关于吸烟替代品的讨论之际。尼古丁袋已成为全球增长最快的尼古丁品类之一，这得益于其隐蔽性、无烟雾或蒸汽的特点，以及人们日益认为它们代表了一种“更清洁”的尼古丁消费方式。
According to a recent report by the World Health Organization, global retail sales of nicotine pouches reached 23.4 billion units in 2024, an increase of more than 50 percent from the previous year, underscoring just how quickly the category is growing. 根据世界卫生组织最近的一份报告，2024 年全球尼古丁袋的零售额达到了 234 亿单位，比上一年增长了超过 50%，这凸显了该品类增长的速度之快。
The FDA announcement comes as the WHO warns that nicotine pouches are spreading so rapidly that regulation is struggling to keep pace in many countries, and that brands are increasingly using social media, influencers, and youth-oriented marketing to promote them. FDA 发布这一公告之际，世卫组织也发出警告称，尼古丁袋的传播速度极快，以至于许多国家的监管措施难以跟上，而且各大品牌正越来越多地利用社交媒体、网红和针对青少年的营销手段来推广这些产品。
It’s the first time regulators have formally endorsed an idea that many younger nicotine users had already embraced. It is not, however, a blessing for the category. In many ways, regulators are simply catching up with a cultural shift that already happened. 这是监管机构首次正式认可许多年轻尼古丁使用者早已接受的观点。然而，这并非是对该品类的“祝福”。在许多方面，监管机构只是在追赶已经发生的文化转变。
Nicotine and Tobacco Alternatives to Cigarettes
尼古丁与烟草的香烟替代品
The market for smoking alternatives has splintered well beyond the offerings of a decade ago. While nicotine-replacement therapies such as patches, gum, and inhalers remain FDA-approved tools designed to help people quit smoking, they now compete with a rapidly expanding ecosystem of alternative nicotine products. 吸烟替代品市场已经分化，远远超出了十年前的产品范围。虽然尼古丁替代疗法（如贴片、口香糖和吸入剂）仍然是 FDA 批准的旨在帮助人们戒烟的工具，但它们现在正与一个迅速扩张的替代尼古丁产品生态系统竞争。
Oral nicotine pouches have rapidly become one of the biggest growth categories. ZYN and other brands like On! and VELO have become the front-runners in the oral nicotine market globally. 口服尼古丁袋已迅速成为增长最快的品类之一。ZYN 以及 On! 和 VELO 等其他品牌已成为全球口服尼古丁市场的领跑者。
Vapes and disposable e-cigarettes, meanwhile, still take the biggest share of the global smoking-alternative category, projected to hit $14.8 billion by 2030 in the US, even though they’re still dogged by headlines about youth use. Heated tobacco devices, like IQOS, offer another choice by heating tobacco instead of burning it, which lowers exposure to many of the harmful chemicals found in cigarette smoke. 与此同时，电子烟和一次性电子烟仍然占据了全球吸烟替代品市场的最大份额，预计到 2030 年在美国的市场规模将达到 148 亿美元，尽管它们仍因有关青少年使用的新闻报道而备受困扰。像 IQOS 这样的加热烟草设备提供了另一种选择，通过加热而非燃烧烟草，从而降低了对香烟烟雾中许多有害化学物质的接触。
The FDA’s New Ruling on ZYN Nicotine Pouches
FDA 关于 ZYN 尼古丁袋的新裁定
Public health officials remain cautious about nicotine pouches. The WHO has warned that they are becoming increasingly popular among adolescents and young adults because of their “strong youth appeal and high addiction potential,” raising concerns that products initially marketed to smokers could also attract new users. 公共卫生官员对尼古丁袋仍持谨慎态度。世卫组织警告称，由于其“对青少年的强烈吸引力和高成瘾潜力”，尼古丁袋在青少年和年轻人中越来越受欢迎，这引发了人们的担忧：最初针对吸烟者营销的产品可能会吸引新的使用者。
Based on toxicology data, consumer research, and public health modeling, though, the FDA gave a Modified Risk Tobacco Product (MRTP) order to 10 ZYN flavors at each of two strengths—3 milligrams and 6 milligrams. This allows Swedish Match to market those specific products as a lower-risk alternative for adults who switch completely away from cigarettes. 不过，基于毒理学数据、消费者研究和公共卫生模型，FDA 向 10 款 ZYN 口味（每种口味包含 3 毫克和 6 毫克两种浓度）颁发了“风险改良烟草产品”（MRTP）令。这允许瑞典火柴公司将这些特定产品作为一种风险较低的替代品，向那些完全戒掉香烟的成年人进行营销。
The new designations are a big win for the tobacco industry, but there are two significant caveats. First, the ruling only applies to 20 specific products, not all nicotine pouches. Second, the FDA’s findings only apply to smokers who fully switch to these pouches. 这一新认定对烟草行业来说是一次重大胜利，但有两个重要的注意事项。首先，该裁定仅适用于 20 款特定产品，而非所有尼古丁袋。其次，FDA 的结论仅适用于完全改用这些尼古丁袋的吸烟者。
Those who use cigarettes or vapes as well as pouches won’t get the same benefit, and the FDA has advised non-tobacco users against using nicotine pouches. “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. He also stated that the decision “informs adults who smoke about the lower risks associated with these products.” 那些既使用香烟或电子烟又使用尼古丁袋的人将无法获得同样的益处，FDA 也建议非烟草使用者不要使用尼古丁袋。FDA 烟草产品中心代理主任布雷特·科普洛（Bret Koplow）表示：“FDA 对风险改良产品的审查旨在确保成年用户获得关于烟草产品相对危害的清晰、基于科学的信息，以便他们做出明智的选择。”他还指出，这一决定“告知了吸烟的成年人与这些产品相关的较低风险。”
Swedish Match must also keep track of real-world usage and report back to the FDA. The MRTP order is valid for five years, unless it is renewed or withdrawn. 瑞典火柴公司还必须跟踪实际使用情况并向 FDA 报告。MRTP 令有效期为五年，除非获得续期或被撤销。
The FDA’s message is relatively straightforward: Adults who smoke and completely switch to certain nicotine pouches are likely reducing their health risks compared to continuing to smoke cigarettes. FDA 传达的信息相对直接：与继续吸烟相比，那些吸烟并完全改用特定尼古丁袋的成年人很可能会降低其健康风险。
But the agency also stresses that there is no safe tobacco product and that fully quitting all tobacco and nicotine products remains the best option for better health. Who ultimately uses nicotine pouches—and whether their rapid growth creates a new generation of nicotine users—is a separate question entirely. 但该机构也强调，不存在安全的烟草产品，完全戒除所有烟草和尼古丁产品仍然是改善健康的最佳选择。最终谁在使用尼古丁袋，以及它们的快速增长是否会造就新一代的尼古丁使用者，则是另一个完全不同的问题。
This story originally appeared on WIRED Middle East. 本文最初发表于《连线》中东版。